Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® Inhaler is a Trademark of the GSK Group of Companies.



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:7/4/2018
Start Date:April 28, 2004
End Date:September 6, 2007

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Double-Blind, Parallel-Group Clinical Trial Evaluating the Effect of the Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Twice Daily Via DISKUS® Inhaler Versus Salmeterol 50mcg Twice Daily Via DISKUS® Inhaler on Bone Mineral Density in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This study will last up to 3 years. You will visit the clinic up to 14 times. Certain visits
will include lung function tests and scans of your bones. The purpose of this study is to
determine the effect of the steroid component of an inhaled product on bone mineral density
in patients with Chronic Obstructive Pulmonary Disease (COPD).


Inclusion criteria:

- Established clinical history of COPD.

- Baseline FEV1 <70% predicted normal, and FEV1/FVC ratio of less than 70%.

- Smoking history of at least 10 pack-years, where both current and former smokers will
be eligible.

- Must have at least one native, evaluable hip.

Exclusion criteria:

- History of or evidence for metabolic bone diseases other than osteoporosis or
osteopenia.
We found this trial at
34
sites
GSK Investigational Site
Charlotte, North Carolina 28203
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Charlotte, NC
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Atlanta, Georgia 30341
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Atlanta, GA
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Bellingham, Washington 98225
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Bellingham, WA
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Berkeley, California 94704
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Berkeley, CA
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Boston, Massachusetts 02115
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Boston, MA
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Bronxville, New York 10708
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Bronxville, NY
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Cadillac, Michigan 49601
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Cadillac, MI
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GSK Investigational Site
Charleston, South Carolina 29425
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Charleston, SC
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GSK Investigational Site
Chicago, Illinois 60611
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Chicago, IL
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GSK Investigational Site
Corsicana, Texas 75110
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Corsicana, TX
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GSK Investigational Site
Fort Collins, Colorado 80528
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Fort Collins, CO
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GSK Investigational Site
Fort Lauderdale, Florida 33308
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Fort Lauderdale, FL
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GSK Investigational Site
Fullerton, California 92835
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Fullerton, CA
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GSK Investigational Site
Greer, South Carolina 29651
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Greer, SC
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GSK Investigational Site
Hartford, Connecticut 06105
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Hartford, CT
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GSK Investigational Site
Jacksonville, Florida 32207
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Jacksonville, FL
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GSK Investigational Site
Kingsport, Tennessee 37660
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Kingsport, TN
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GSK Investigational Site
Milan, Tennessee 38372
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Milan, TN
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GSK Investigational Site
North Chicago, Illinois 60064
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North Chicago, IL
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GSK Investigational Site
Omaha, Nebraska 68131
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Omaha, NE
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GSK Investigational Site
Portland, Oregon 97227
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Portland, OR
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GSK Investigational Site
Rancho Mirage, California 92270
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Rancho Mirage, CA
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GSK Investigational Site
Richmond, Virginia 23298
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Richmond, VA
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GSK Investigational Site
Saint Charles, Missouri 63301
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Saint Charles, MO
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San Antonio, Texas 78258
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San Antonio, TX
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GSK Investigational Site
San Diego, California 92111
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San Diego, CA
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GSK Investigational Site
Sarasota, Florida 34232
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Sarasota, FL
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GSK Investigational Site
Simpsonville, South Carolina 29681
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Simpsonville, SC
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GSK Investigational Site
Spartanburg, South Carolina 29303
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Spartanburg, SC
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GSK Investigational Site
Spokane, Washington 99208
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Spokane, WA
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GSK Investigational Site
Tamarac, Florida 33319
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Tamarac, FL
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GSK Investigational Site
Walnut Creek, California 94596
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Walnut Creek, CA
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GSK Investigational Site
Wheat Ridge, Colorado 80033
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Wheat Ridge, CO
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GSK Investigational Site
Wichita, Kansas 67207
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Wichita, KS
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